MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G)(8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The complaint of resistance during attempted insertion was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The catheter had been advanced and was received loose.Usage residues were observed throughout the sample.The safety mechanism was partially advanced along the needle shaft but did not cover the needle tip.Curved shape memory was observed along the catheter shaft.The catheter tip appeared to exhibit deformation.The guidewire was advanced to the locked position and was intact.The wire exhibited curved shape memory within the coil region.Microscopic inspection of the catheter confirmed deformation throughout the distal tip.The edges were buckled and flared outward.Inspection of the needle revealed deformation along the proximal edge of the bevel.The guidewire and catheter deformation were consistent with attempted insertion against resistance.Such resistance may occur if insertion is attempted into tissue or at a sharp insertion angle.The needle deformation was consistent with damage caused by retraction of the wire against the needle.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported by the customer that there were issues with the advancement.Patient needed to be stuck again as it made for an unsuccessful insertion.No other information was provided.02/15/2024 - the catheter, guidewire, and needle returned for evaluation exhibited deformations.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G)(8CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18804054
• MDR Text Key: 336624119
• Report Number: 3006260740-2024-00814
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REGV1325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other